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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202236


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NDA 202236 describes DYMISTA, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the DYMISTA profile page.

The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 202236
Pharmacology for NDA: 202236
Suppliers and Packaging for NDA: 202236
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236 NDA Meda Pharmaceuticals Inc. 0037-0245 0037-0245-23 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY
DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-3458 0378-3458-23 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.137MG/SPRAY;0.05MG/SPRAY
Approval Date:May 1, 2012TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 29, 2024Product Flag?Substance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Aug 24, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 202236

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Sign Up ⤷  Sign Up
Mylan Speciality Lp DYMISTA azelastine hydrochloride; fluticasone propionate SPRAY, METERED;NASAL 202236-001 May 1, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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